JP6821789B2 - Reagent composition dispensing cap for reagent containers used in automated clinical analyzers - Google Patents

Reagent composition dispensing cap for reagent containers used in automated clinical analyzers Download PDF

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JP6821789B2
JP6821789B2 JP2019504772A JP2019504772A JP6821789B2 JP 6821789 B2 JP6821789 B2 JP 6821789B2 JP 2019504772 A JP2019504772 A JP 2019504772A JP 2019504772 A JP2019504772 A JP 2019504772A JP 6821789 B2 JP6821789 B2 JP 6821789B2
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housing
reagent
seal
cylindrical member
lumen
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JP2019525177A (en
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ブランケンスタイン,ゲルト
ツェン,ハンソン
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インストゥルメンテーション ラボラトリー カンパニー
インストゥルメンテーション ラボラトリー カンパニー
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/52Containers specially adapted for storing or dispensing a reagent
    • B01L3/523Containers specially adapted for storing or dispensing a reagent with means for closing or opening
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D39/00Closures arranged within necks or pouring openings or in discharge apertures, e.g. stoppers
    • B65D39/08Threaded or like closure members secured by rotation; Bushes therefor
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/24Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/28Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
    • B65D51/2807Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/24Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/28Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
    • B65D51/2807Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container
    • B65D51/2814Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it
    • B65D51/2828Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it said element being a film or a foil
    • B65D51/2835Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it said element being a film or a foil ruptured by a sharp element, e.g. a cutter or a piercer
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/24Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/28Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
    • B65D51/2807Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container
    • B65D51/2857Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by displacing or removing an element enclosing it
    • B65D51/2864Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by displacing or removing an element enclosing it the element being a plug or like element closing a passage between the auxiliary container and the main container
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/24Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/28Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
    • B65D51/2807Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container
    • B65D51/2857Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by displacing or removing an element enclosing it
    • B65D51/2892Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by displacing or removing an element enclosing it the element, e.g. a valve, opening an aperture of the auxiliary container
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3205Separate rigid or semi-rigid containers joined to each other at their external surfaces
    • B65D81/3211Separate rigid or semi-rigid containers joined to each other at their external surfaces coaxially and provided with means facilitating admixture
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02Adapting objects or devices to another
    • B01L2200/025Align devices or objects to ensure defined positions relative to each other
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06Fluid handling related problems
    • B01L2200/0689Sealing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16Reagents, handling or storing thereof
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/042Caps; Plugs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/044Connecting closures to device or container pierceable, e.g. films, membranes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/046Function or devices integrated in the closure
    • B01L2300/047Additional chamber, reservoir
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0672Integrated piercing tool
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0832Geometry, shape and general structure cylindrical, tube shaped
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/12Specific details about materials
    • B01L2300/123Flexible; Elastomeric
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0475Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0478Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure pistons
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N2035/1027General features of the devices
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1002Reagent dispensers

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)

Description

本発明は、体外診断(IVD)検査手順に関する。より詳細には、本発明は、診断検査で使用され、自動臨床分析装置において実施される試薬の試薬組成物の貯蔵及び混合のための試薬容器用の試薬組成物分注キャップを提供する。本発明はさらに、試薬分注キャップの使用方法を提供する。 The present invention relates to in vitro diagnostic (IVD) testing procedures. More specifically, the present invention provides reagent composition dispensing caps for reagent containers for storage and mixing of reagent compositions of reagents used in diagnostic testing and performed in automated clinical analyzers. The present invention further provides a method of using the reagent dispensing cap.

現在利用可能な体外診断(IVD)検査手順では、試薬が液状及び/又は粉末状での使用のために調製され得る前に人手の介入を伴う非常に多くのステップが負担となっている。例えば、診断検査室において、一般的には、全血、血漿、血清、尿、脳脊髄液などの患者の体液の試料検査のために試薬を使用する前に、医療従事者は、別個のバイアル/ボトルから異なる試薬組成物を収集し、ピペットを使用して一定量の希釈剤を粉末試薬のバイアル又は濃縮液試薬のバイアルに移して、一定時間、再構成するのを待ち、最後に、例えば、手で振る、かき混ぜる、又は回転させることによって試薬を混合する。この手動プロセスは、診断検査完了速度を低下させ、人為的ミス及び潜在的有毒化学物質による作業者の汚染のリスクを高め、包装にかかるコストを上昇させる。 Currently available in vitro diagnostic (IVD) testing procedures are burdened with numerous steps involving manual intervention before reagents can be prepared for use in liquid and / or powder form. For example, in a diagnostic laboratory, medical personnel generally use separate vials before using reagents for sample testing of patient body fluids such as whole blood, plasma, serum, urine, cerebrospinal fluid, etc. / Collect different reagent compositions from the bottle, transfer a certain amount of diluent to a vial of powder reagent or vial of concentrate reagent using a pipette, wait for a period of time to reconstitute, and finally, for example, Mix the reagents by shaking, stirring, or rotating by hand. This manual process slows the rate of completion of diagnostic tests, increases the risk of human error and contamination of workers by potentially toxic chemicals, and increases packaging costs.

試薬の調製における上記の欠点に加えて、試薬容器(例えば、バイアル又はボトル)内の試薬組成物は、試薬容器が臨床分析装置内に配置されたときに蒸発しやすい。試薬(単数又は複数)の蒸発は、試薬安定性の一貫性を損ない、試薬を無駄にしてしまう。 In addition to the above drawbacks in reagent preparation, the reagent composition in a reagent container (eg, vial or bottle) is prone to evaporation when the reagent container is placed in a clinical analyzer. Evaporation of reagents (s) compromises the consistency of reagent stability and wastes reagents.

さらに重要なことには、試薬の蒸発は、臨床分析装置によって得られた結果の一貫性を損ない、結果は信頼性を欠いたものとなってしまう。したがって、自動臨床分析装置内で実施される診断検査で使用するための試薬の組成物を貯蔵及び混合するための試薬容器を改良する必要がある。さらに、試薬調製プロセスを改善し、自動臨床分析装置におけるIVD用途の試薬容器の使用効率を高める必要もある。上記の不利点に対処する試薬の包装の解決策について、後述する。 More importantly, evaporation of the reagent compromises the consistency of the results obtained by the clinical analyzer, resulting in unreliable results. Therefore, it is necessary to improve the reagent container for storing and mixing the composition of the reagent for use in the diagnostic test performed in the automatic clinical analyzer. In addition, there is a need to improve the reagent preparation process and increase the efficiency of use of reagent containers for IVD applications in automated clinical analyzers. A reagent packaging solution that addresses the above disadvantages will be described below.

本明細書で説明するのは、複数の組成物の貯蔵、自動再構成ならびに貯蔵組成物の混合、及び貯蔵組成物の蒸発防止に関する試薬包装の解決策である。 Described herein are reagent packaging solutions for storage, automatic reconstitution and mixing of storage compositions, and prevention of evaporation of storage compositions.

一態様では、本発明は、自動臨床分析装置における試薬組成物の貯蔵及び分注のための装置を対象とする。本発明のこの態様の装置は、第1端部及び隣接する第1開口部と、第2端部及び隣接する第2開口部と、雌ねじ部とを有するハウジングを備え、雌ねじ部はハウジングの内表面の少なくとも一部に沿って延在する。ハウジングは、ハウジングの第1端部と第2端部との間に配置されたルーメンを有するチャンバを画定する。ハウジングの第1端部に配置された円筒状部材は、第1端部と第2端部とを備える。円筒状部材は、ハウジングの少なくとも雌ねじ部と螺合する雄ねじ部を有する。円筒状部材は、ハウジングの雌ねじ部上で回転可能であり、ハウジングの第1端部から前記ハウジングの第2端部に向かって並進可能である。本発明のこの態様の一実施形態では、ハウジングの第2端部と円筒状部材の第2端部との間でチャンバの第2端部のルーメンを横断するようシールが配置されている。 In one aspect, the invention is directed to an apparatus for storage and dispensing of reagent compositions in an automated clinical analyzer. The device of this aspect of the present invention comprises a housing having a first end and an adjacent first opening, a second end and an adjacent second opening, and a female thread, the female thread of which is inside the housing. It extends along at least a portion of the surface. The housing defines a chamber with lumens located between the first and second ends of the housing. The cylindrical member disposed at the first end of the housing comprises a first end and a second end. The cylindrical member has a male threaded portion that is threaded with at least a female threaded portion of the housing. The cylindrical member is rotatable on the female threaded portion of the housing and can be translated from the first end of the housing towards the second end of the housing. In one embodiment of this aspect of the invention, a seal is arranged between the second end of the housing and the second end of the cylindrical member across the lumen of the second end of the chamber.

本発明のこの態様の一実施形態では、該装置は、シールと円筒状部材の第2端部との間のチャンバのルーメン内に収容されている試薬組成物を含む。一実施形態では、円筒状部材の第1端部に、アクチュエータが動作可能に配置される。アクチュエータは、ラム、ニードル、又は回転可能な円筒状部材を特徴とし得る。 In one embodiment of this aspect of the invention, the device comprises a reagent composition housed within the lumen of the chamber between the seal and the second end of the cylindrical member. In one embodiment, the actuator is operably arranged at the first end of the cylindrical member. Actuators can feature rams, needles, or rotatable cylindrical members.

本発明のこの態様のさまざまな実施形態では、該装置は、円筒状部材と一体になって、円筒状部材に接合され得るシールを含む。ハウジングの第2端部に、容器に嵌合させるための取付片が配置され得る。さまざまな実施形態の取付片は、ねじ山、スナップロック、メイティングリング、受容溝、摩擦嵌合機構、ルアーロック、もしくは1つ又は複数のタブから成り得る。容器と螺合するための複数の雄ねじ部は、ハウジングの第1端部の外表面に配置され得る。該装置はさらに、ハウジングの第1開口部を可逆的に封止するためのキャップを特徴とし得る。 In various embodiments of this aspect of the invention, the device comprises a seal that can be integrated with the cylindrical member and joined to the cylindrical member. A mounting piece for fitting into the container may be placed at the second end of the housing. Mounting pieces of various embodiments may consist of threads, snap locks, mating rings, receiving grooves, friction fitting mechanisms, luer locks, or one or more tabs. A plurality of male threads for screwing with the container may be arranged on the outer surface of the first end of the housing. The device may further feature a cap for reversibly sealing the first opening of the housing.

別の態様では、本発明は、試薬を貯蔵及び分注するための装置であって、長軸と、第1端部及び隣接する第1開口部と、第2端部及び隣接する第2開口部とを有するハウジングを備える装置を対象とする。ハウジングは、第1端部と第2端部とに間に配置されたルーメンを有するチャンバと、チャンバのルーメンを横断するように配置された変形可能部材とを画定する。変形可能部材は、ハウジングの第2端部に最も近い変形可能な膜の側に配置された尖った先端を含む穿刺プローブを含む。本発明のこの態様では、チャンバのルーメンを封止するためのシールが、ハウジングの第2端部と穿刺プローブの先端との間のチャンバのルーメン内に配置される。試薬を貯蔵するためのチャンバは、シールと変形可能部材との間に配置される。本発明のこの態様の装置は、前記ハウジングの第2端部に、容器に嵌合させるための取付片を含む。取付片は、スナップロック機構、摩擦嵌合機構、ねじ山、1つ又は複数のタブ、受容溝、メイティングリング、ルアーロック、もしくは1つ又は複数の溝であり得る。本発明のこの態様の装置はさらに、ハウジングの第1開口部を可逆的に封止するためのキャップと、該装置を作動させるためのラムとを特徴とし得る。 In another aspect, the invention is a device for storing and dispensing reagents, the major axis, the first end and the adjacent first opening, the second end and the adjacent second opening. The object is a device including a housing having a portion. The housing defines a chamber having lumens located between the first and second ends and a deformable member arranged across the lumens of the chamber. The deformable member includes a puncture probe containing a pointed tip located on the side of the deformable membrane closest to the second end of the housing. In this aspect of the invention, a seal for sealing the lumen of the chamber is placed within the lumen of the chamber between the second end of the housing and the tip of the puncture probe. A chamber for storing reagents is placed between the seal and the deformable member. The device of this aspect of the invention includes a mounting piece at the second end of the housing for fitting into a container. The mounting piece can be a snap lock mechanism, a friction fitting mechanism, a thread, one or more tabs, a receiving groove, a mating ring, a luer lock, or one or more grooves. The device of this aspect of the invention may further feature a cap for reversibly sealing the first opening of the housing and a ram for operating the device.

別の態様では、本発明は、試薬を貯蔵及び分注するための装置であって、上述したような円筒状ハウジングと、チャンバのルーメン内に配置されて横方向に摺動可能なプラグとを備える装置を対象とする。プラグは、プラグ内に、ハウジングの長軸に平行な貫通孔を画定する。貫通孔は、試薬組成物のような物質を貯蔵するためのリザーバを含む。物質は、貫通孔がチャンバのルーメンと位置合わせされたときに、リザーバから放出される。本発明のこの態様の装置は、前記ハウジングの第2端部に、容器に嵌合させるための取付片を含む。取付片はさまざまな実施形態では、スナップロック機構、摩擦嵌合機構、ねじ山、1つ又は複数のタブ、受容溝、メイティングリング、ルアーロック、もしくは1つ又は複数のタブである。 In another aspect, the present invention is a device for storing and dispensing reagents, the cylindrical housing as described above and a plug located within the lumen of the chamber and slid laterally. The target is the device to be equipped. The plug defines a through hole in the plug parallel to the long axis of the housing. The through hole contains a reservoir for storing a substance such as a reagent composition. The material is released from the reservoir when the through hole is aligned with the lumen of the chamber. The device of this aspect of the invention includes a mounting piece at the second end of the housing for fitting into a container. Mounting pieces are, in various embodiments, snap lock mechanisms, friction fitting mechanisms, threads, one or more tabs, receiving grooves, mating rings, luer locks, or one or more tabs.

別の態様では、本発明は、本明細書で記載されている装置のさまざまな実施形態に従って自動臨床分析装置内で診断試薬を調製するために、試薬組成物を試薬分注キャップ内に貯蔵し、試薬組成物を自動混合する方法を対象とする。 In another aspect, the invention stores the reagent composition in a reagent dispensing cap to prepare diagnostic reagents in an automated clinical analyzer according to various embodiments of the devices described herein. , A method of automatically mixing reagent compositions.

本発明の一実施形態に係る、容器に解除可能に接合された例示的な試薬分注キャップの長手方向断面図である。FIG. 5 is a longitudinal sectional view of an exemplary reagent dispensing cap leasably joined to a container according to an embodiment of the present invention. 本発明の一実施形態に係る、図1Aの試薬分注キャップのハウジング及び円筒状部材の分解断面図である。FIG. 5 is an exploded sectional view of a housing and a cylindrical member of the reagent dispensing cap of FIG. 1A according to an embodiment of the present invention. 本発明の一実施形態に係る、容器の上部に接合された例示的なシールを含む図1Aの試薬分注キャップのハウジングの部分断面図である。FIG. 5 is a partial cross-sectional view of the housing of the reagent dispensing cap of FIG. 1A, comprising an exemplary seal bonded to the top of the container, according to an embodiment of the invention. 本発明の一実施形態に係る、円筒状部材の第2端部とシールとの間に位置するチャンバ内に配置された第1試薬組成物を示す例示的な試薬分注キャップの部分断面図である。In a partial cross-sectional view of an exemplary reagent dispensing cap showing a first reagent composition disposed in a chamber located between a second end of a cylindrical member and a seal according to an embodiment of the present invention. is there. 本発明の一実施形態に係る、円筒状部材の第2端部とシールとの間に位置するチャンバ内に配置された第1試薬組成物を入れたブリスターパック示す例示的な試薬分注キャップの部分断面図である。An exemplary reagent dispensing cap of a blister pack containing a first reagent composition disposed in a chamber located between a second end of a cylindrical member and a seal according to an embodiment of the invention. It is a partial sectional view. 本発明の一実施形態に係る、円筒状部材の端部に第1試薬組成物が配置された状態の例示的な試薬分注キャップの部分断面図である。FIG. 5 is a partial cross-sectional view of an exemplary reagent dispensing cap in a state in which the first reagent composition is arranged at the end of a cylindrical member according to an embodiment of the present invention. 本発明の一実施形態に係る、円筒状部材の第1端部にラムを当てることによって生じる図1Aに示されているシールと円筒状部材の第2端部との間に収容された第1試薬組成物に向けた円筒状部材の軸方向回転を示す本発明の試薬分注キャップの断面図である。A first housed between a seal shown in FIG. 1A and a second end of a cylindrical member, which is produced by applying a ram to the first end of the cylindrical member according to an embodiment of the present invention. It is sectional drawing of the reagent dispensing cap of this invention which shows the axial rotation of a cylindrical member toward a reagent composition. 本発明の一実施形態に係る、針を含む変形可能な膜とシールとの間に位置するチャンバ内に配置された第1試薬組成物を示す例示的な試薬分注キャップの部分断面図である。FIG. 5 is a partial cross-sectional view of an exemplary reagent dispensing cap showing a first reagent composition disposed in a chamber located between a deformable membrane containing a needle and a seal according to an embodiment of the present invention. .. 本発明の一実施形態に係る、円筒状部材の第2端部に軸方向に配置された針を含む例示的な試薬分注キャップの断面図である。FIG. 5 is a cross-sectional view of an exemplary reagent dispensing cap comprising a needle arranged axially at a second end of a cylindrical member according to an embodiment of the present invention. 本発明の一実施形態に係る、円筒状部材の第1端部にラムを当てることによって生じる図4Aに示されているシールと円筒状部材の第2端部との間に収容された第1試薬組成物に向けた円筒状部材の軸方向回転を示す本発明の試薬分注キャップの部分断面図である。A first housed between the seal shown in FIG. 4A and the second end of the cylindrical member, which is produced by applying a ram to the first end of the cylindrical member according to an embodiment of the present invention. It is a partial cross-sectional view of the reagent dispensing cap of this invention which shows the axial rotation of a cylindrical member toward a reagent composition. ねじなしハウジングとねじなし円筒状部材とを含む本発明の試薬分注キャップの別の実施形態を示す図である。It is a figure which shows another embodiment of the reagent dispensing cap of this invention which includes a screwless housing and a screwless cylindrical member. ラムを円筒状部材の第1端部に当てて円筒状部材の反対側端部を取り付け容器のルーメンへと押し込むことにより第1試薬組成物を容器内に分注するための図5Aの試薬分注キャップの動作を示す図である。Reagent component of FIG. 5A for dispensing the first reagent composition into the container by applying the ram to the first end of the cylindrical member and pushing the opposite end of the cylindrical member into the lumen of the container. Note It is a figure which shows the operation of a cap. ハウジングがスライダを含む本発明の試薬分注キャップのさらに別の実施形態を示す図である。FIG. 5 illustrates yet another embodiment of the reagent dispensing cap of the present invention, the housing comprising a slider. 第1試薬組成物を取り付け容器のルーメンへと放出するための図6Aのスライダの動作を示す図である。It is a figure which shows the operation of the slider of FIG. 6A for discharging the 1st reagent composition into the lumen of a mounting container.

診断分析に使用される試薬を作製するために別の貯蔵組成物と組み合わせるべき少なくとも1つの貯蔵組成物を別々に貯蔵して自動的に分注するための自動試薬分注キャップ、及び血液凝固分析装置、免疫分析装置、化学分析装置などを含む自動臨床分析装置内で使用するときに貯蔵組成物を分注する方法について後述する。貯蔵される試薬組成物(単数又は複数)(すなわち、試薬組成物の1つ又は複数)は、自由に、又は膜(例えば、穿刺可能な膜)を使用する小袋、ブリスターパック、ピル、バッグのような一次包装の形で、又は1つ又は複数の試薬組成物を含むアンプルの形で、試薬分注キャップ内に収容される。貯蔵試薬組成物は、液状(例えば、濃縮物)、ゲル状、又は乾燥組成物の形態(例えば、粉末、タブレット、凍結乾燥形態、又は粒状形態)であり得る。 An automated reagent dispensing cap for storing and automatically dispensing at least one storage composition that should be combined with another storage composition to make reagents used for diagnostic analysis, and blood coagulation analysis. A method of dispensing the storage composition when used in an automated clinical analyzer including an apparatus, immunoanalyzer, chemical analyzer and the like will be described later. The stored reagent compositions (s) (ie, one or more of the reagent compositions) can be freely or in sachets, blister packs, pills, bags that use a membrane (eg, a punctureable membrane). Such as in the form of a primary package, or in the form of an ampoule containing one or more reagent compositions, is housed in a reagent dispensing cap. The storage reagent composition can be in the form of a liquid (eg, concentrate), gel, or dry composition (eg, powder, tablet, lyophilized, or granular).

[0026] 本発明の試薬分注キャップ内の貯蔵試薬組成物(単数又は複数)は、酸素又は水分が貯蔵試薬組成物(単数又は複数)の化学的又は物理的性質に影響を及ぼすのを防ぐ方法で貯蔵される。一実施形態では、キャップ内に貯蔵されている試薬組成物(単数又は複数)とキャップの周囲の外部環境との接触を最小限に抑えるために、キャップの一端にシールキャップが設けられる。このように試薬組成物(単数又は複数)を貯蔵することにより、蒸発による試薬組成物(単数又は複数)の損失が最小限に抑えられる。 The storage reagent composition (s) in the reagent dispensing cap of the present invention prevents oxygen or water from affecting the chemical or physical properties of the storage reagent composition (s). Stored by the method. In one embodiment, a seal cap is provided at one end of the cap to minimize contact between the reagent composition (s) stored in the cap and the external environment surrounding the cap. By storing the reagent composition (s) in this way, the loss of the reagent composition (s) due to evaporation is minimized.

[0027] 本発明の試薬分注キャップは、液体、ゲル、又は乾燥組成物(例えば、粉末、タブレット、凍結乾燥形態、又は粒状形態)の形態で第2試薬組成物を収容する容器上に配置される。試薬分注キャップの内容物は、例えば、これに限定されないが、ラムのようなプランジャによって作動されるキャップ又はキャップの一部を回転させる又は押圧することによって分注キャップと容器との間のエラストマー膜のようなシールを破り、キャップから貯蔵組成物を接合容器内に放出するような開封機構によって接合容器内へ分注される。試薬分注キャップ内の組成物と、試薬キャップの組成物と混合される容器内の組成物とのさまざまな組み合わせ及び調整が本発明によって想定される。 [0027] The reagent dispensing cap of the present invention is placed on a container containing the second reagent composition in the form of a liquid, gel, or dry composition (eg, powder, tablet, lyophilized, or granular form). Will be done. The contents of the reagent dispensing cap are, for example, but not limited to, an elastomer between the dispensing cap and the container by rotating or pressing a cap operated by a plunger such as a ram or a portion of the cap. It is dispensed into the bonded container by an opening mechanism that breaks the membrane-like seal and releases the storage composition into the bonded container from the cap. Various combinations and adjustments of the composition in the reagent dispensing cap and the composition in the container to be mixed with the composition of the reagent cap are envisioned by the present invention.

上記ならびに他の目的は、本明細書に示す本発明の利点及び特徴と共に、以下の説明及び特許請求の範囲を参照することで明らかになるであろう。さらに、本明細書に示されているさまざまな構成要素の特徴は、相互排他的ではなく、さまざまな組み合わせ及び置換形態で存在可能であることを理解されたい。 The above and other objectives will become apparent by reference to the following description and claims, along with the advantages and features of the invention set forth herein. Moreover, it should be understood that the features of the various components presented herein are not mutually exclusive and can exist in different combinations and substitution forms.

一態様では、本発明は、自動臨床分析装置、例えば、血液凝固分析装置(ACLTOP(登録商標)(Instrumentation Laboratory Company、ベッドフォード、マサチューセッツ州))内で使用するための診断試薬を作製するために容器内の別の組成物と組み合わせるべき少なくとも1つの試薬の貯蔵及び容器への自動分注のための装置を対象とする。 In one aspect, the invention is used to make diagnostic reagents for use in automated clinical analyzers, such as blood coagulation analyzers (ACLTOP® (Instrumentation Laboratory Company, Bedford, Mass.)). A device for storing at least one reagent to be combined with another composition in a container and for automatic dispensing into a container is intended.

図1A〜図1Cを参照すると、本発明の自動試薬分注キャップ10は、第1端部20及び隣接する第1開口部21と、第2端部22及び隣接する第2開口部23とを有する円筒状ハウジング12を含む。ハウジング12は、第1端部20と第2端部22との間にルーメン24を有するチャンバ62を画定する。チャンバ62は、ハウジング12の第1端部20から第2端部22まで延在し得る、又は以下でさらに詳細に説明するように、ハウジング12の第2端部22に向けて閉じ込められ得る。本発明の一実施形態では、シールキャップ100は、ハウジング12の第1端部20に配置される。 Referring to FIGS. 1A to 1C, the automatic reagent dispensing cap 10 of the present invention has a first end portion 20 and an adjacent first opening 21 and a second end portion 22 and an adjacent second opening 23. Includes a cylindrical housing 12 having. The housing 12 defines a chamber 62 having a lumen 24 between the first end 20 and the second end 22. The chamber 62 can extend from the first end 20 to the second end 22 of the housing 12, or can be confined towards the second end 22 of the housing 12, as described in more detail below. In one embodiment of the invention, the seal cap 100 is located at the first end 20 of the housing 12.

本発明の一実施形態では、チャンバ62は、第1試薬組成物を貯蔵し、第1試薬組成物は、接合容器72内に貯蔵されている第2試薬組成物(単数又は複数)と混合されたときに、診断分析用の試薬となる。ハウジング12はさらに、ハウジングの内壁に沿って延在し、好ましくは、これに限定されないが、ハウジング10の第1端部20から第2端部22まで延在する雌ねじ部30を含む。 In one embodiment of the invention, the chamber 62 stores the first reagent composition, which is mixed with the second reagent composition (s) stored in the junction vessel 72. At that time, it becomes a reagent for diagnostic analysis. The housing 12 further includes a female thread 30 extending along the inner wall of the housing, preferably but not limited to, extending from the first end 20 to the second end 22 of the housing 10.

続いて図1A及び図1Bを参照すると、本発明の一実施形態では、試薬分注キャップ10はさらに、長軸と、ハウジング12の第1開口部21の近くの第1端部42と、第1端部42の反対側の第2端部44とを有する円筒状部材40を含む。円筒状部材40は、ルーメン24内に配置され、ハウジング12の長軸に沿って配置される。円筒状部材40は、ハウジング12の雌ねじ部30と螺合するように配置された雄ねじ部50を含む。円筒状部材40は、ハウジング12の雌ねじ部30上で雌ねじ部30を中心として回転可能である。円筒状部材40の雄ねじ部50とハウジング12のねじ部30との螺合は、キャップ10内の試薬内容物が水分又は酸素のような外部要素に触れるのを防ぎ、さらにハウジング12内の試薬内容物の蒸発を防ぐ。 Subsequently referring to FIGS. 1A and 1B, in one embodiment of the invention, the reagent dispensing cap 10 further comprises a major axis and a first end 42 near the first opening 21 of the housing 12. Includes a cylindrical member 40 having a second end 44 on the opposite side of one end 42. The cylindrical member 40 is arranged in the lumen 24 and is arranged along the long axis of the housing 12. The cylindrical member 40 includes a male screw portion 50 arranged so as to be screwed with the female screw portion 30 of the housing 12. The cylindrical member 40 is rotatable about the female threaded portion 30 on the female threaded portion 30 of the housing 12. The screwing between the male threaded portion 50 of the cylindrical member 40 and the threaded portion 30 of the housing 12 prevents the reagent contents in the cap 10 from coming into contact with external elements such as water or oxygen, and further prevents the reagent contents in the housing 12 from coming into contact with external elements. Prevents evaporation of things.

図1A〜図1Cを参照すると、さらにシールキャップ100が、チャンバ62内の試薬組成物(単数又は複数)がキャップ10の周囲の外部環境の酸素又は水分と接触するのを防ぐ、又は最小限に抑える。シールキャップ100はさらに、試薬分注キャップ10内の試薬組成物(単数又は複数)の蒸発を最小限に抑える。 Referring to FIGS. 1A-1C, the seal cap 100 further prevents or minimizes contact of the reagent composition (s) in the chamber 62 with oxygen or moisture in the external environment surrounding the cap 10. suppress. The seal cap 100 further minimizes evaporation of the reagent composition (s) within the reagent dispensing cap 10.

図1Cに示されているように、本発明の一実施形態では、試薬分注キャップ10はさらに、円筒状ハウジング12のチャンバ62の第2端部22に配置された脆弱膜のようなシール60を含む。シール60は、チャンバ62の内容物が、接合容器72内に貯蔵されている第2試薬組成物(単数又は複数)と混ざるのを防ぐ。この実施形態では、円筒状部材40の第2端部44とシール60との間の空間は、チャンバ62の境界を画定する。 As shown in FIG. 1C, in one embodiment of the invention, the reagent dispensing cap 10 is further a fragile membrane-like seal 60 located at the second end 22 of the chamber 62 of the cylindrical housing 12. including. The seal 60 prevents the contents of the chamber 62 from mixing with the second reagent composition (s) stored in the joining vessel 72. In this embodiment, the space between the second end 44 of the cylindrical member 40 and the seal 60 defines the boundary of the chamber 62.

図2Aに示されているように、一実施形態では、チャンバ62は、自由に配置された液状又は粉末状の第1試薬組成物を収容する。あるいは、図2Bを参照すると、チャンバ62は、第1試薬組成物を入れたパック(例えば、ブリスターパック又はアンプル)のようなパケット64を収容する。あるいは、図2Cに示されているように、第1試薬組成物は、例えば、第2端部44の表面に塗ることによって、又は試薬組成物を円筒状部材40の第2端部44に接合されたフォイル43内に閉じ込めることによって、円筒状部材40の第2端部44上に配置される。 As shown in FIG. 2A, in one embodiment, the chamber 62 houses a freely arranged liquid or powdered first reagent composition. Alternatively, referring to FIG. 2B, chamber 62 contains a packet 64, such as a pack (eg, a blister pack or ampoule) containing the first reagent composition. Alternatively, as shown in FIG. 2C, the first reagent composition may be applied, for example, to the surface of the second end 44, or the reagent composition may be joined to the second end 44 of the cylindrical member 40. By confining it in the foil 43, it is placed on the second end 44 of the cylindrical member 40.

図3A及び図3Bを参照すると、他の実施形態では、1つ又は複数の試薬組成物は、試薬分注キャップ内に、例えば、小袋、ピル、又はバッグのようなパケット内に配置される。1つ又は複数の試薬組成物がパケット内に貯蔵される場合、パケットは、ピストン、例えば、円筒状部材40、穿刺プローブ74(例えば、針)によって、又は以下でさらに詳細に説明するように、試薬分注キャップ10を捻ること(例えば、キャップ10の回転運動)によって破られ得る。 With reference to FIGS. 3A and 3B, in other embodiments, one or more reagent compositions are placed within a reagent dispensing cap, eg, in a packet such as a pouch, pill, or bag. When one or more reagent compositions are stored in a packet, the packet is delivered by a piston, eg, a cylindrical member 40, a puncture probe 74 (eg, a needle), or as described in more detail below. It can be broken by twisting the reagent dispensing cap 10 (eg, the rotational movement of the cap 10).

ここで図3Aを参照すると、本発明の一実施形態では、試薬分注キャップ10の円筒状部材40は、ラム70を円筒状部材40の第1端部42に当てることによって、螺合した円筒状部材の雄ねじ部50とハウジング12の雌ねじ部30を介して、接合される容器72に向けて軸方向に回転するように作動される。図3Aに示されているように、円筒状部材40は、チャンバ62の内容物を圧縮し、そのことによりシール60を破って、チャンバ62の内容物を容器72内へと放出し、そこで内容物が第2試薬組成物と接触する。 Here, referring to FIG. 3A, in one embodiment of the present invention, the cylindrical member 40 of the reagent dispensing cap 10 is a cylinder screwed by applying the ram 70 to the first end 42 of the cylindrical member 40. It is operated so as to rotate in the axial direction toward the container 72 to be joined via the male screw portion 50 of the shape member and the female screw portion 30 of the housing 12. As shown in FIG. 3A, the cylindrical member 40 compresses the contents of the chamber 62, thereby breaking the seal 60 and discharging the contents of the chamber 62 into the container 72, where the contents. The material comes into contact with the second reagent composition.

あるいは、図3Bを参照すると、試薬組成物を貯蔵するためのチャンバ62は、円筒状部材40の第2端部44側のチャンバ62の片側の変形可能なダイアフラム80と、チャンバ62の反対側のシール60(例えば、穿刺可能な膜)とによって囲まれる。本発明の一実施形態では、変形可能なダイアフラム80は、軸方向にシール60に向けて延びる鋭く尖った先端(例えば、針)を備える穿刺プローブ74を含む。 Alternatively, referring to FIG. 3B, the chamber 62 for storing the reagent composition is a deformable diaphragm 80 on one side of the chamber 62 on the second end 44 side of the cylindrical member 40 and the opposite side of the chamber 62. Surrounded by a seal 60 (eg, a punctureable membrane). In one embodiment of the invention, the deformable diaphragm 80 includes a puncture probe 74 with a sharply pointed tip (eg, a needle) that extends axially toward the seal 60.

図4A及び図4Bに示されている本発明の一実施形態では、円筒状部材40は、円筒状部材40の第2端部44に軸方向に配置された鋭く尖った先端(例えば、針)を備える穿刺プローブ74を含む。図4Bに最もわかりやすく示されているように、円筒状部材40はラム70によってシール60に向けて回転されるので、シール60、又はパケット(例えば、ブリスターパックもしくは小袋64)が穿刺され、その内容物が容器72内へと放出され、そこで内容物は容器72内に入れられている第2試薬組成物と接触する。 In one embodiment of the invention shown in FIGS. 4A and 4B, the cylindrical member 40 has a sharply pointed tip (eg, a needle) axially located at the second end 44 of the cylindrical member 40. Includes a puncture probe 74 comprising. As most clearly shown in FIG. 4B, the cylindrical member 40 is rotated towards the seal 60 by the ram 70, so that the seal 60, or packet (eg, blister pack or pouch 64), is punctured and its. The contents are released into the container 72, where the contents come into contact with the second reagent composition contained in the container 72.

図5A及び図5Bを参照すると、試薬分注キャップ10のさらに別の実施形態では、ハウジング12及び円筒状部材40は、ねじ部を備えない。この実施形態では、円筒状部材40は、ハウジング12の第2端部22の一部に一体チャンバ80を含む。一体チャンバ80は、第1試薬組成物を収容する。シール60は、ハウジング12の第2端部22において、チャンバ80の容器側に配置される。ラム70は、円筒状部材40の第1端部42に当てられて、チャンバ80のシール60が容器72のルーメンへと導入されるまで、円筒状部材40を軸方向に容器72に向けて軸方向に押圧し、チャンバ80の内容物は放出されて、容器72の内容物と接触する。 With reference to FIGS. 5A and 5B, in yet another embodiment of the reagent dispensing cap 10, the housing 12 and the cylindrical member 40 do not include threads. In this embodiment, the cylindrical member 40 includes an integral chamber 80 in a portion of the second end 22 of the housing 12. The integral chamber 80 houses the first reagent composition. The seal 60 is located on the container side of the chamber 80 at the second end 22 of the housing 12. The ram 70 is applied to the first end 42 of the cylindrical member 40 and shafts the cylindrical member 40 axially toward the container 72 until the seal 60 of the chamber 80 is introduced into the lumen of the container 72. Pressed in the direction, the contents of the chamber 80 are released and come into contact with the contents of the container 72.

図6A〜図6Bは、円筒状部材を含まない試薬分注キャップ10の一実施形態を示す。図6Aを参照すると、この実施形態の試薬分注キャップ10は、中央で軸方向に配置されたルーメン11を有するハウジング12を含む。ハウジング12は、横方向に(矢印7)、すなわち、ハウジング12のルーメン11に垂直な方向に、移動可能なスライダ9(例えば、摺動可能なプラグ)を含む。スライダ9は、例えば、円盤状、長方形又は円筒形であり得る。スライダ9は、試薬組成物を試薬分注キャップ10内に収容するためのチャンバ5のような1つ又は複数の貫通孔を含む。チャンバ5は、試薬分注キャップ10に接合される容器72に面するチャンバ5の端部で開口している。図6Bを参照すると、チャンバ5は、スライダ9が臨床分析装置内のアクチュエータ(図示せず)によって横方向に押された、又は引っ張られたときに、ハウジング12のルーメン11内へと横方向に摺動可能である。チャンバ5がルーメン11内に配置されるときに、図6Bに示されているように、チャンバ5内に収容されている試薬組成物が、試薬分注キャップ10に接合されている容器72内へと放出される。 6A-6B show an embodiment of the reagent dispensing cap 10 that does not include a cylindrical member. Referring to FIG. 6A, the reagent dispensing cap 10 of this embodiment includes a housing 12 having a centrally axially located lumen 11. The housing 12 includes a movable slider 9 (eg, a slidable plug) laterally (arrow 7), i.e., perpendicular to the lumen 11 of the housing 12. The slider 9 can be, for example, disc-shaped, rectangular or cylindrical. The slider 9 includes one or more through holes, such as a chamber 5, for accommodating the reagent composition within the reagent dispensing cap 10. The chamber 5 is open at the end of the chamber 5 facing the container 72 joined to the reagent dispensing cap 10. Referring to FIG. 6B, the chamber 5 laterally into the lumen 11 of the housing 12 when the slider 9 is laterally pushed or pulled by an actuator (not shown) in the clinical analyzer. It is slidable. When the chamber 5 is placed in the lumen 11, as shown in FIG. 6B, the reagent composition contained in the chamber 5 enters the container 72 bonded to the reagent dispensing cap 10. Is released.

試薬分注キャップ10は、容器72に可逆的に取り付け可能である。例えば、再び図1A及び図1Bを参照すると、試薬分注キャップ10のハウジング12の第2端部22は、試薬分注キャップ10を容器72に接合するための取付具75を含む。取付片75は、例えば、容器の開口端部の雄ねじ部と螺合するハウジング12の第2端部22の雌ねじ部、又はスナップロック、受容溝、摩擦嵌合部、ルアーロック、もしくは1つ又は複数のタブであり得る。 The reagent dispensing cap 10 can be reversibly attached to the container 72. For example, referring again to FIGS. 1A and 1B, the second end 22 of the housing 12 of the reagent dispensing cap 10 includes a fixture 75 for joining the reagent dispensing cap 10 to the container 72. The mounting piece 75 is, for example, a female threaded portion of the second end 22 of the housing 12 that is screwed with a male threaded portion of the open end of the container, or a snap lock, a receiving groove, a friction fitting portion, a luer lock, or one or one. It can be multiple tabs.

試薬分注キャップ10の不注意による作動を防止するために、例えば、図5Aに示されているような不正開封防止開封帯76が、試薬分注キャップ10と容器72との間に配置される場合がある。 In order to prevent inadvertent operation of the reagent dispensing cap 10, for example, an unauthorized opening prevention opening band 76 as shown in FIG. 5A is arranged between the reagent dispensing cap 10 and the container 72. In some cases.

本発明は、キャップ10内のセクション(例えば、ハウジング12)を利用して、試薬組成物の化学的もしくは物理的性質又はその両方の性質を変化させてしまうような水分又は酸素に試薬組成物を触れさせることなく、そしてキャップ10内の試薬組成物を接合容器72内の試薬組成物と混合させずに、液状又は乾燥形態の1つ又は複数の試薬組成物を別々に貯蔵するために、複数の組成物の試薬を貯蔵するという利点を提供する。試薬組成物は予め混合されず、試薬の劣化をもたらすようなより長期間貯蔵されるので、必要に応じてキャップ10内に貯蔵されている試薬組成物を接合容器72内の試薬組成物と混合することで、信頼性の高い結果ももたらすという追加の利益が得られる。 The present invention utilizes a section within the cap 10 (eg, housing 12) to bring the reagent composition to water or oxygen that would alter the chemical and / or physical properties of the reagent composition. Multiple to store one or more reagent compositions in liquid or dry form separately, without touching and without mixing the reagent composition in cap 10 with the reagent composition in bonding vessel 72. Provides the advantage of storing reagents for the composition of. Since the reagent composition is not premixed and is stored for a longer period of time that causes deterioration of the reagent, the reagent composition stored in the cap 10 is mixed with the reagent composition in the bonding container 72 as needed. This has the additional benefit of also providing reliable results.

1つ又は複数の試薬組成物を接合容器72内へと自動分注する前にキャップ10のセクション(例えば、ハウジング12)内に貯蔵することで、ハウジング10内の組成物及び接合容器72内の組成物の蒸発を最小限に抑えられる。ハウジング12及び容器72内に別々に貯蔵されている試薬組成物の放出及び混合が自動化されるので、偶発的な人の介入が最小限に抑えられる。本明細書に示されている本発明は、調製された試薬の長期貯蔵及び劣化によって引き起こされる分析結果の誤り、及び人の介入によって引き起こされる試薬組成物の偶発的損失を最小限に抑える。これらの特徴は、試薬のコスト効率及び患者試料の分析を向上させる。 By storing one or more reagent compositions in a section of the cap 10 (eg, housing 12) prior to automatic dispensing into the bonding container 72, the composition in housing 10 and the bonding container 72 Evaporation of the composition can be minimized. The release and mixing of the reagent compositions, which are separately stored in the housing 12 and the container 72, are automated, minimizing accidental human intervention. The present invention presented herein minimizes analytical results errors caused by long-term storage and degradation of the prepared reagents, and accidental loss of reagent compositions caused by human intervention. These features improve the cost efficiency of reagents and the analysis of patient samples.

自動臨床血液凝固分析機器における血液凝固検査用の例示的なデュアルチャンバ試薬混合容器 An exemplary dual-chamber reagent mixing vessel for blood coagulation testing in automated clinical blood coagulation analyzers

上述した本発明の試薬分注キャップの特定の非限定的な例は、自動血液凝固分析機器によるプロトロンビン時間(PT)検査用の試薬分注キャップである。PT検査用の試薬は、希釈剤と濃縮PT試薬との2つの組成物を含む。希釈剤とPT試薬との容積比は、19:1である。個々のPT検査には、100μlの希釈PT試薬が必要である。自動臨床分析装置におけるPT検査に有用な試薬分注キャップでは、一般に、約500〜1000回のPT検査が必要である。1000回のPT検査用の試薬分注キャップでは、約100mlの希釈PT試薬、すなわち、95mlの希釈剤と5mlの濃縮PT試薬とが必要である。本明細書に開示されている例示的な試薬キャップ(例えば、図1に示されている試薬キャップ及び容器)では、試薬分注キャップが試薬を放出する先の容器72は、100mlより多い容積容量を有し、最初に95mlの希釈剤を含む。試薬キャップのチャンバは、5mlの濃縮PT試薬を含む。上述の実施形態に示されている円筒状部材によって作動されると、5mlの濃縮PT試薬は容器内へと導入され、容器72内に入れられている第2試薬組成物と接触する。したがって、約1000回のPT分析に対して持続可能な自動試薬調製式の自己完結型PT試薬分注キャップ10が実現される。 A particular non-limiting example of the reagent dispensing cap of the present invention described above is a reagent dispensing cap for prothrombin time (PT) testing with an automated blood coagulation analyzer. Reagents for PT testing include two compositions, a diluent and a concentrated PT reagent. The volume ratio of the diluent to the PT reagent is 19: 1. Individual PT tests require 100 μl of diluted PT reagent. Reagent dispensing caps useful for PT testing in automated clinical analyzers generally require about 500-1000 PT testing. A reagent dispensing cap for 1000 PT tests requires about 100 ml of diluted PT reagent, ie 95 ml of diluent and 5 ml of concentrated PT reagent. In the exemplary reagent caps disclosed herein (eg, the reagent caps and containers shown in FIG. 1), the container 72 to which the reagent dispensing cap releases the reagent has a volume volume greater than 100 ml. First contains 95 ml of diluent. The reagent cap chamber contains 5 ml of concentrated PT reagent. Actuated by the cylindrical member shown in the embodiment above, 5 ml of concentrated PT reagent is introduced into the container and contacts the second reagent composition contained in the container 72. Therefore, a self-contained self-contained PT reagent dispensing cap 10 with a sustainable automatic reagent preparation formula is realized for about 1000 PT analyzes.

自動臨床分析装置における分析検査用の例示的なデュアルチャンバ試薬混合容器 An exemplary dual-chamber reagent mixing vessel for analytical testing in automated clinical analyzers

本発明の試薬分注キャップの第2非限定的な例は、例えば、血液凝固の品質管理(QC)試薬用の分注キャップである。既知の分析検査結果を有する特別に調製された凍結乾燥血漿試料が、QC試薬となる。QC試薬は、試薬分注キャップが接合される容器内に貯蔵される。試薬分注キャップのチャンバには、脱イオン水が貯蔵される。使用前に、脱イオン水が試薬分注キャップのチャンバから凍結乾燥QC試薬を入れた容器へと導入される。 A second non-limiting example of the reagent dispensing cap of the present invention is, for example, a dispensing cap for quality control (QC) reagents for blood coagulation. A specially prepared lyophilized plasma sample with known analytical test results is the QC reagent. The QC reagent is stored in a container to which the reagent dispensing cap is joined. Deionized water is stored in the chamber of the reagent dispensing cap. Prior to use, deionized water is introduced from the chamber of the reagent dispensing cap into a container containing the lyophilized QC reagent.

Claims (9)

自動臨床分析装置における試薬組成物の貯蔵のための装置であって、
試薬分注キャップを備え、
前記試薬分注キャップは、
長軸の周囲に配置され、ルーメンを画定する、ハウジングと、
前記ハウジングの第1端部にある前記ルーメンの第1開口と、
前記ハウジングの第2端部にある前記ルーメンの第2開口と、
1つ又は複数の試薬組成物を貯蔵するためのチャンバを画定する、前記ルーメンの一部と、
前記ハウジングに含まれ、前記ハウジングの前記第1端部から前記ハウジングの前記第2端部まで延在する雌ねじ部と、
前記ルーメンの内部に配置されている円筒状部材であって、前記円筒状部材は、前記ハウジングの前記雌ねじ部と螺合するように配置されている雄ねじ部を有し、前記雌ねじ部と前記雄ねじ部との螺合によって、前記ルーメンの内部において前記長軸に沿って移動され、前記雌ねじ部と前記雄ねじ部との前記螺合は、前記ルーメンの前記第1開口部と前記チャンバとの間のシール構成を形成し、前記ルーメンの前記第1開口部と前記チャンバとの間の前記シール構成は、前記チャンバの内部にある試薬内容物が外部の酸素及び/又は水分との接触を有効に防ぐ、円筒状部材と、
前記ハウジングの前記第2端部に配置されているシールであって、前記シールは、前記ルーメンの前記第2開口を横断するように広がり、前記チャンバは、前記ハウジング、前記円筒状部材及び前記シールによって囲まれている、シールと、
前記ハウジングの前記第2端部に嵌合されている取付片であって、前記取付片は、容器の開口部で前記容器の嵌合部と係合するための形状をなしている係合部を有し、前記容器の前記開口が前記シールによって封止されるように、前記ハウジング及び前記シールを前記容器に対して固定位置に保持する、取付片と、を含む、
装置。
A device for storing reagent compositions in an automated clinical analyzer,
Equipped with reagent dispensing cap,
The reagent dispensing cap is
With the housing, which is placed around the long axis and defines the lumen,
With the first opening of the lumen at the first end of the housing,
With the second opening of the lumen at the second end of the housing,
With a portion of the lumen, which defines a chamber for storing one or more reagent compositions,
A female thread portion included in the housing and extending from the first end portion of the housing to the second end portion of the housing.
A cylindrical member disposed inside the lumen, wherein the cylindrical member includes the internal thread portion and the male screw portion being arranged to be screwed in said housing, a front Kimesu threaded portion By screwing with the male threaded portion, it is moved along the long axis inside the lumen, and the screwing between the female threaded portion and the male threaded portion is formed between the first opening of the lumen and the chamber. The seal configuration between the first opening of the lumen and the chamber forms a seal configuration between the chambers so that the reagent contents inside the chamber are in contact with external oxygen and / or moisture. To prevent, with a cylindrical member,
A seal located at the second end of the housing, the seal extending across the second opening of the lumen, the chamber being the housing, the cylindrical member and the seal. It is surrounded by, and seal,
A mounting piece fitted to the second end of the housing, the mounting piece having a shape for engaging with the fitting portion of the container at the opening of the container. Includes a mounting piece that holds the housing and the seal in a fixed position with respect to the container so that the opening of the container is sealed by the seal.
apparatus.
自動臨床分析装置における試薬組成物の貯蔵及び分注のための装置であって、
第1端部及び隣接する第1開口部と、第2端部及び隣接する第2開口部と、ウジングの内表面に沿って延在する雌ねじ部と、を有し、前記ハウジングの前記第1端部及び前記第2端部の間に位置するルーメンを有するチャンバを画定する、ハウジングと、
前記ハウジングの前記第1端部に配置されている第1端部と、第2端部と、前記ハウジングの少なくとも前記雌ねじ部と螺合する雄ねじ部と、を有し、前記ハウジングの前記雌ねじ部上で回転可能であるとともに、前記ハウジングの前記第1端部から前記ハウジングの前記第2端部に向かって並進可能である、円筒状部材と、
前記ハウジングの前記第2端部と、前記円筒状部材の前記第2端部との間で前記チャンバの前記ルーメンを横断するように配置されている、シールと、
を備え、
前記シールは、前記円筒状部材の前記第2端部と一体になり、前記円筒状部材の前記第2端部に接合される、装置。
A device for storing and dispensing reagent compositions in an automated clinical analyzer.
It has a first opening for the first end and adjacent the second opening to the second end and adjacent, and the internal thread portion extending along the inner surface of the housings, the said of said housing first A housing and a housing that defines a chamber with lumens located between one end and the second end.
The housing has a first end portion arranged at the first end portion, a second end portion, and a male screw portion screwed with at least the female screw portion of the housing, and the female screw portion of the housing. A cylindrical member that is rotatable on and translatable from the first end of the housing towards the second end of the housing.
A seal that is disposed between the second end of the housing and the second end of the cylindrical member across the lumen of the chamber.
With
A device in which the seal is integrated with the second end of the cylindrical member and joined to the second end of the cylindrical member .
前記取付片は、ねじ山、スナップロック、メイティングリング、受容溝、摩擦嵌合機構、ルアーロックつ又は複数のタブとを有するグループから選択される、請求項1に記載の装置。 The mounting piece, threads and a snap-lock, a mating ring, and receiving groove, a friction fit mechanism, a luer lock, is selected from the group having one or more tabs, claim 1 The device described in. 前記試薬分注キャップは、前記容器に可逆的に取り付け可能である、請求項1に記載の装置。 The apparatus according to claim 1, wherein the reagent dispensing cap can be reversibly attached to the container. 前記ハウジングの前記第1端部に配置されているシールキャップをさらに備え、
前記シールキャップは、前記円筒状部材を閉じ込めるとともに、前記ルーメンの前記第1開口を封止する、請求項1に記載の装置。
Further comprising a seal cap located at the first end of the housing
The device according to claim 1, wherein the seal cap encloses the cylindrical member and seals the first opening of the lumen.
前記取付片を介して前記試薬分注キャップに連結されている前記容器をさらに備える、請求項1に記載の装置。 The apparatus according to claim 1, further comprising the container connected to the reagent dispensing cap via the mounting piece. 前記試薬分注キャップの前記チャンバに貯蔵されている第1試薬組成物と、
合容器内に別々に貯蔵されている第2試薬組成物と、
をさらに備え、
前記第1試薬組成物及び前記第2試薬組成物は、前記シールによって互いに分離されている、請求項6に記載の装置。
The first reagent composition stored in the chamber of the reagent dispensing cap and
A second reagent composition are stored separately in the junction container,
With more
The apparatus according to claim 6, wherein the first reagent composition and the second reagent composition are separated from each other by the seal.
前記第1試薬組成物は、前記円筒状部材が前記長軸に沿って前記シールに向かって移動することに応じて、前記シールを破り、前記第2試薬組成物と混合することができる、請求項7に記載の装置。 The first reagent composition is capable of breaking the seal and mixing with the second reagent composition as the cylindrical member moves toward the seal along the long axis. Item 7. The apparatus according to item 7. 前記円筒状部材から前記シールに向かって伸びる穿刺プローブ、をさらに備え、
前記穿刺プローブは、前記円筒状部材が前記長軸に沿って前記シールに向かって移動することに応じて、前記シールを穿刺するように設けられている尖った先端を有する、請求項1に記載の装置。
Further comprising a puncture probe extending from the cylindrical member towards the seal.
The puncture probe according to claim 1, wherein the puncture probe has a pointed tip provided to puncture the seal as the cylindrical member moves toward the seal along the long axis. Equipment.
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